Informations générales (source: ClinicalTrials.gov)

NCT03915262 En recrutement
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy (IPEC)
Observational
  • Maladie de Crohn
  • Insuffisance pancréatique exocrine
Hospices Civils de Lyon (Voir sur ClinicalTrials)
novembre 2019
novembre 2026
05 avril 2025
This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL - 69495 - Pierre Benite - France Gilles BOSCHETTI, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Age of 18 years or more

- Crohn's disease diagnosed for more than 3 months.

- Active Crohn's disease : CDAI score > 150 + [CRP > 5 mg/L or faecal calprotectin >
250mcg/g or endoscopic lesion or MRI lesion]

- Indication of a biological therapy (anti-TNFα, vedolizumab ou ustekinumab).


- Crohn's disease that doesn't fit the previous criteria

- Extended resection of small intestine (>40cm)

- Chronic pancreatitis diagnosed before inclusion

- Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)

- Pancreatic enzyme replacement therapy

- Pregnant or breastfeeding woman

- Patient under the protection of a conservator